The disclosure relates to an electrical stimulation device for treatment of an individual or animal, for example via transcutaneous electrical muscle stimulation. Conditions that are treatable with the disclosed electrical stimulation device include, without limitation, stress incontinence, urge incontinence, mixed incontinence, male urinary incontinence, pelvic prolapse, vulvodynia, complications following prostate removal and fecal incontinence. Aspects described herein serve to drive improved patient compliance relative to known treatments.
Electric muscle stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS) have proven effective tools for toning and retraining muscles as well as calming or stimulating nerves. Important to its efficacy is the ability to stimulate the specific muscles and/or reach certain nerves, and this is complicated when the targeted muscles are deep within the patient's tissue. Several factors impact the ability of the delivered electric current to stimulate deep tissue muscles including the shape and frequency of the pulse waveform, the electrode size and configuration, positioning of the electrodes, and the continuity of the electrode-skin interface.
Urinary incontinence, as an exemplary condition, affects as many as one third of woman over the age of 30. One cause is a weakening of pelvic floor muscles. Clinical studies have shown EMS and/or TENS to be effective at resolving the symptoms of incontinence; however, two thirds of women who suffer from incontinence forgo medical treatment. Their failure to adopt or comply with EMS or TENS treatment regimens is at least partly due to the manner in which the stimulation is provided. One known method is through surgical implantation of a sacral nerve stimulator. Such implantable devices are relatively permanent and pose inherent risks including infection. EMS and/or TENS treatment is also commonly provided via an intravaginal probe. Many women have psychological and physiological challenges accepting this form of treatment. Further, its configuration necessitates usage in a private location, limiting many patients' ability to obtain treatment multiple times per day. Thirdly, conventional EMS electrode pads can be applied to the perineal tissues of the patient in patterns aimed at stimulating the pelvic floor muscles. This commonly requires four electrode pads and placement by a trained clinician. As with the other stimulation devices, these surface electrodes have proven effective, but they are difficult for an individual to apply to herself, are difficult to maintain in contact for an extended period of time, are difficult to administer multiple times per day, fail to accommodate leakage, and do not allow discreet use.
Thus a need exists for a device to deliver EMS treatment to the pelvic floor that is easy to apply, can be worn for an extended period of time, allows multiple convenient treatments per day, can accommodate leakage and be worn discreetly by the user.